$185.00 – $3,690.00
Each tablet for oral administration contains 5 mg, 15 mg or 30 mg of oxycodone hydrochloride USP.
Oxycodone hydrochloride is a white, odourless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol-water partition coefficient is 0.7).
Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17methylmorphinan-6-one hydrochloride
ROXICODONE (oxycodone hydrochloride) tablets
Is an immediate-release oral formulation of oxycodone hydrochloride. It is for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
DOSAGE AND ADMINISTRATION
If the pain increases in severity, if analgesia is not adequate, a gradual increase in dosage you may require.
Patients who don’t take opioid analgesics have to start in a dosing range of 5 to 15 mg every 4 to 6 hours for pain. The dose has to be same as the individual patient’s response to their initial dose. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia considering side effects experienced by the patient.
For control of severe chronic pain, ROXICODONE should be administered on a regularly scheduled basis. Every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.
As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually. Taking into account the patient’s prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose, attention should be given to the daily dose and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2) the reliability of the relative potency estimate to calculate the dose of oxycodone needed, 3) the degree of opioid tolerance, 4) the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.
Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs
When also converting patients from a constant ratio opioid/non-opioid drug regimens you must make a decision whether or not to continue the non-opioid analgesic. If a decision happens to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of ROXICODONE in response to the level of analgesia and adverse effects that occur by the dosing regimen. If the non-opioid regimen continues as a separate single entity agent. The starting dose must be with regards to the most recent dose of opioid as a baseline for further titration of oxycodone. Incremental increases must happen according to side effects to an acceptable level of analgesia.
Patients Currently on Opioid Therapy
If a patient has is receiving opioid-containing medications. Before taking ROXICODONE, the potency of the prior opioid relative to oxycodone must be put down into the selection of the total daily dose (TDD) of oxycodone.
In converting patients from other opioids to ROXICODONE. Close observation and adjustment of dosage regarding the patient’s response to ROXICODONE is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose may be necessary. Especially in patients who have disease states that are changing rapidly.
Maintenance of Therapy
Continual re-evaluation of the patient receiving ROXICODONE (oxycodone hydrochloride) is important. With special attention to the maintenance of pain control and the relative incidence of side effects as a result of therapy. If the level of pain increases, put effort to identify the source of pain, while adjusting the dose as we describe above to decrease the level of pain.
During chronic therapy, especially for non-cancer-pain (or pain like other terminal illnesses). The continuous need for the use of opioid analgesics you have to re-assess as appropriate.
Cessation of Therapy
When a patient no longer requires therapy with ROXICODONE for the treatment of their pain. Therapy must gradually be put to stop over time to prevent the development of opioid abstinence syndrome (narcotic withdrawal). In general, therapy must decrease by 25% to 50% per day with careful monitoring for symptoms of withdrawal. If the patient develops these signs. The dose has to take a raise to the former level and also put down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. There is no specific dose of ROXICODONE that treatment may stop without risk of the opioid abstinence syndrome.
10 mg, 15 mg, 20 mg, 5 mg